AIDS-RELATED ORAL MALIGNANCIES AND TUMORS
RELEASE DATE: October 31, 2003
RFA Number: RFA-DE-05-001
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidcr.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):
No. 93.121, Oral Diseases and Disorders Research
LETTER OF INTENT RECEIPT DATE: May 18, 2004
APPLICATION RECEIPT DATE: June 16, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of This RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The purpose of this initiative is to stimulate research that will
improve our understanding of the biological basis of development and
progression of AIDS-related oral cancers and tumors, and to encourage
research identifying novel targets for treatment, and biomarkers for
early diagnosis and monitoring of disease progression. The role of
chronic latent viruses of the oral cavity and their interaction with
one another or with environmental factors in the context of HIV
infection leading to the development of tumors or lesions with
oncogenic potential is especially sought.
RESEARCH OBJECTIVES
Background
HIV infection is a major public health problem throughout the world.
The hallmark of this infection is a gradual depletion of CD 4+ T cells
which eventually leads to a state of immunosuppression. This
immunosuppression predisposes the patients to warts, preneoplastic oral
lesions and oral cancers. Some of these neoplasms are aggressive, hard
to treat and can affect the quality of life of the patients. Oral
malignancies and tumors affect up to 25% of patients with AIDS. The
most frequent oral malignancies are Kaposi’s sarcoma (KS) and non-
Hodgkin’s lymphoma. Oral warts and oral hairy leukoplakia (OHL), a
benign epithelial hyperplasia of the lingual squamous epithelium, have
also been shown to increase among patients with HIV infection.
The incidence of some of these conditions has changed following the
introduction of highly active antiretroviral therapy (HAART). For
example, the incidence of KS has significantly decreased, while
plasmablastic lymphoma has increased. The latter is a diffuse large B-
cell lymphoma with a unique immunophenotype and appears to be
associated with Epstein Barr virus (EBV). EBV is also associated with
OHL and nasopharyngeal carcinoma. Human papillomavirus (HPV), another
DNA virus, has been associated with the development of oral warts. The
incidence of these warts appears to be increasing in the HAART era.
Occasionally the oral warts in HIV infected patients show marked
epithelial dysplasia. Recently the presence of HPV 16 and 18 in oral
warts of some AIDS patients has been reported. HPV 16 has previously
been implicated in invasive squamous cell carcinoma of the head and
neck. However, until the patients are followed for an extended period
of time, the risk for development of squamous cell carcinomas from oral
dysplastic warts will remain unknown.
The biological basis for AIDS-related oral lesions is not yet clear.
There appears to be an emerging role for various concurrent viral
infections in the HIV-infected host that are likely implicated in the
pathogenesis of these ailments. For the purpose of this RFA the oral
lesions of interest are the ones associated with concomitant infection
with viruses that frequently confer latency, such as EBV, human
herpesvirus 8 and HPV. In each case, the infection by each concomitant
virus appears to be necessary, but not sufficient, for subsequent tumor
development.
Interestingly, the genomes of some of the viruses that are associated
with the oral complications of HIV infection have sequence homology
with some human cytokines and/or chemokines. For example,
cytomegalovirus encodes vIL10 and CXC1&2, EBV encodes vIL10 and HHV-8
encodes vIL6. The role of this mimicry to cellular cytokines in disease
pathogenesis is not known. IL10 and IL6 are known to mediate Th2 cell
responses and to inhibit Th1 immune responses. IL6 is also known to
stimulate lymphocyte proliferation.
Patients with HIV-related salivary gland disease present with signs and
symptoms similar to those of patients with Sjögren’s syndrome. The
condition is characterized by lymphocytic infiltration of the salivary
glands and lymphoepithelial cysts of the major salivary glands and is
part of diffuse interstitial lymphocytosis syndrome. Occasionally,
lymphomas may develop within the salivary glands. The search for an
etiology for this disease has so far been inconclusive. The incidence
of salivary gland disease among HIV infected patients appear to has
increased following the introduction of HAART. The cause of this
increase is not known at the present time.
Scope
The objective of this RFA is to encourage research on the mechanisms
and factors involved in the initiation and progression of AIDS–related
oral malignancies, their detection and management. Multidisciplinary
approaches and collaborations are encouraged. Examples of research
responsive to this RFA are listed below but are by no means inclusive:
o Studies to characterize the host genetic susceptibility to AIDS-
related oral malignancies and tumors in patients with HIV infection.
o Studies to determine the pathogenic mechanisms involved in EBV, HHV-
8, and HPV mediated tumor initiation and promotion of malignancies of
the oral cavity. For example, the interaction of viral gene products
with cellular factors involved in the regulation of the cell cycle.
o Studies to determine the cellular proteome and transcriptome of
virally-induced tumors of the oral cavity in the context of HIV
infection.
o Studies to determine the mode of entry, latency, reactivation and
transformation of oncogenic viruses of mucosal cells of the oral
cavity.
o Studies to determine the interactions of HIV structural and non-
structural proteins with oncogenic viruses and their role in
potentiation of transformation.
o Studies to identify novel molecular targets for therapeutic
interventions for oral KS and non-Hodgkin’s lymphoma.
o Studies to determine the immunological mechanisms that are involved
in EBV, HPV and HHV-8 driven oral malignancies and tumors, in the
context of HIV infection.
o Studies to determine the effect of prolonged moderate
immunosuppression or incomplete or failed responses to HAART on the
development of oral malignancies and tumors.
o Studies to determine the effect of the concomitant prolonged exposure
of HIV infected patients to antiretroviral therapy and viruses with
oncogenic potential on the development of AIDS-related oral
malignancies and pre-neoplastic lesions.
o Studies to determine the molecular epidemiology of the viral strains
that are implicated in the promotion of AIDS-related malignant
transformations of the oral cavity.
o Development of animal and cell based models for AIDS-related oral
malignancies.
o Studies to determine the similarities and differences between AIDS-
related tumors of the oral mucosa and other anatomical mucosal
surfaces, e.g. vaginal and gastrointestinal.
o Studies that are geared towards identifying reliable diagnostic and
prognostic biomarkers, useful for detection of AIDS-related oral
malignancies and their progression.
MECHANISM OF SUPPORT
This RFA will use NIH individual research project grant (R01) and the
exploratory/development research grant (R21) award mechanisms. As an
applicant you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation.
Future unsolicited, competing-continuation applications based on this
project will compete with all investigator-initiated applications and
will be reviewed according to the customary peer review procedures.
This RFA uses just-in-time concepts. It also uses the modular as well
as the non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in
each year of $250,000 or less, use the modular format. Otherwise
follow the instructions for non-modular research grant applications.
This program does not require cost sharing as defined in the current
NIH Grants Policy Statement at
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
The NIDCR intends to commit approximately $2,000,000 total cost in FY
2005 to fund 6 to 8 new and/or competitive continuation grants in
response to this RFA. An R01 applicant may request a project period of
up to 4 years and a budget for direct costs of up to $499,999 per year.
An R21 applicant may request a project period of up to two years with a
combined budget for direct costs of up to $275,000 for the two year
period. For example, the applicant may request $100,000 in the first
year and $175,000 in the second year. The request should be tailored
to the needs of the project. Normally, no more than $200,000 may be
requested in any single year. This R21 cap may be exceeded by $25,000,
direct costs per year to accommodate the facilities and administrative
(indirect) costs associated with collaborative research at another
institution. Because the nature and scope of the proposed research will
vary from application to application, it is anticipated that the size
and duration of each award will also vary. Although the financial plans
of the NIDCR provide support for this program, awards pursuant to this
RFA are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit an application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Grantees will meet annually at or near NIH, Bethesda, MD, to share
results, to ensure that the NIDCR has a coherent view of the advances
in the field, and to have an opportunity for collective problem solving
among investigators. Applicants should budget for travel in their
requested budget for the principal investigator and one additional
young investigator to attend this annual meeting.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Mostafa Nokta, MD, PhD.
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial research
Building 45, Room 4AN-18H
45 Center Drive
Bethesda MD, 20892-6402
Telephone: (301) 594-7985
Fax (301) 480-8319
Email: Mostafa.Nokta@nih.gov
o Direct your questions about peer review issues to:
H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44F
45 Center Drive
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
Fax: (301) 480-8303
Email: George.Hausch@nih.gov
o Direct your questions about financial or grants management matters
to:
Mary Daley
Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive MSC 6402
Building 45, Room 4AN-44B
45 Center Drive
Bethesda, MD 20892-6402
Telephone: (301)-594-4808
Fax: (301)-480-3562
Email: md74u@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows NIDCR staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to Dr. Hausch at
the address listed above.
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 document is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS FOR R21 APPLICATIONS
All application instructions outlined in the PHS 398 application kit
are to be followed with the following modifications for R21
applications:
1. FACE PAGE, Item 6: Up to a total of two years of support may be
requested. Total direct costs for the two years may not exceed
$275,000.
2. RESEARCH PLAN: Items a-d may not exceed fifteen (15) pages,
including tables and figures. The following information should be
taken into account for items a, b and c:
o Item a, SPECIFIC AIMS--The instructions for this section suggest that
the applicant state "the hypotheses to be tested". Since some
applications submitted in response to this RFA may also be design- or
problem-driven (e.g., development of novel technologies), or need-
driven (initial research to develop a body of data upon which future
research will build), hypothesis testing per se may not be the driving
force in developing such a proposal and, therefore, may not be
applicable. The application should state the hypotheses, design,
problem and/or need which will drive the proposed research.
o Item b, BACKGROUND AND SIGNIFICANCE--In this section, it is
important to identify clearly how the application addresses the
specific objectives of this RFA and the purpose of the R21
mechanism.
o Item c, PRELIMINARY STUDIES/PROGRESS REPORT—No preliminary data are
required for an R21 application.
3. APPENDIX. Up to five articles may be submitted as appendix
materials.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in
a modular grant format. The modular grant format simplifies the
preparation of the budget in these applications by limiting the level
of budgetary detail. Applicants request direct costs in $25,000
modules. Section C of the research grant application instructions for
the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants. Additional information
on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, original copy of
the application, including the Checklist, and three signed,
photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, send two additional copies of the
application and all copies of the appendix material to:
H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44F
45 Center Drive
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov
APPLICATION PROCESSING: Applications must be received on or before June
16, 2004. If an application is received after that date, it will be
returned to the applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIDCR. Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration. Applications that are complete and responsive to the RFA
will be evaluated for scientific and technical merit by an appropriate
peer review group convened by the NIDCR in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NIDCR National Advisory Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the
following aspects of the application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals. The scientific review group will address and
consider each of these criteria in assigning the application’s overall
score, weighting them as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high
priority score. For example, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to
move a field forward.
SIGNIFICANCE: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project? Does the applicant acknowledge potential problem areas and
consider alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
ENVIRONMENT: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy
of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
R21 APPLICATIONS: The potential for ground-breaking, precedent-
setting research, with particular emphasis on novel and innovative
approaches; and the potential to stimulate new concepts or approaches
regarding important biomedical/behavioral problems, or provide a
technique/system of wide applicability.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: May 18, 2004
Application Receipt Date: June 16, 2004
Peer Review Date: August 2004
Council Review: September/October 2004
Earliest Anticipated Start Date: December 1, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required
for all types of clinical trials, including physiologic, toxicity, and
dose-finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risk to
the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide
for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition
of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1,
1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:
NIH policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide, in the project description and elsewhere in the application as
appropriate, the official NIH identifier(s)for the hESC line(s)to be
used in the proposed research. Applications that do not provide this
information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the “Standards for Privacy of Individually Identifiable
Health Information”, the “Privacy Rule,” on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as “covered entities”) must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on “Am
I a covered entity?” Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284)and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.